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Vytorin Linked to Heart Attacks, Stroke and Liver Damage
Vytorin, a drug prescribed to treat high cholesterol, is a combination of the cholesterol-lowering Zetia and the statin Zocor. Since its FDA approval in 2004, serious Vytorin side effects have been reported, including Vytorin liver problems and statin cardiomyopathy, which can lead to Vytorin heart attack. Furthermore, the ENHANCE study in 2008 showed that Vytorin was no better than an older and cheaper statin. Vytorin lawyers are currently evaluating Vytorin lawsuits.
Vytorin was approved by the FDA in 2004 to treat high cholesterol. A combination of cholesterol-lowering Zetia, which blocks absorption of cholesterol in the intestine, and the generic Zocor (simvastatin), the pink pill was believed to work by attacking both sources of cholesterol: absorption of cholesterol in the intestine and cholesterol produced in the liver and peripheral tissues.
Cholesterol is the biggest moneymaker for the pharmaceutical industry. Approximately 19 million American adults take a cholesterol-lowering medicine of some kind. About 15 percent of people 20 and older and one in four people 65 and older are prescribed statins, one of the most common cholesterol medications. Vytorin is prescribed over 100,000 times each day and generates over $5 billion in annual sales for Merck and Schering-Plough, the co-makers of Vytorin.
According to the National Cholesterol Education guidelines, about 36 million Americans should be on some form of statin therapy. However, critics of the drug industry claim that these guidelines are biased toward drug therapy because a majority of the medical experts who drew up those suggestions have financial relationships with drug companies.
In early 2008, Merck and Schering-Plough released a study called ENHANCE (below), that showed Vytorin was no better than an older and less expensive generic simvastatin (Zocor): it had no effect on the build-up of plaque in the arteries, although it did decrease bad cholesterol levels. But the manufacturer waited two years to announce the results of the study; according to Vytorin lawsuits, the negative study would decrease sales.
Other studies have addressed Vytorin safety issues, particularly liver and heart problems. Vytorin lowers low-density lipoprotein (LDL, or bad cholesterol). Statins, the largest family of cholesterol inhibitors and for the longest time the most potent, directly inhibit HMG-CoA reductase, the rate limiting enzyme of cholesterol synthesis. Inhibition can cause myopathy, a severe muscle wasting condition, and elevated liver enzymes.
On March 19, 2010, the FDA warned of rhabdomyolysis risk, a severe form of muscle damage, in patients taking the highest approved dose of Zocor (80mg). Rhabdomyolysis can lead to kidney damage, kidney failure and death. And recent studies have linked Vytorin to statin Cardiomyopathy
In June 2011 the US Food and Drug Administration issued a warning about simvastatin side effects. Simvastatin (known by the brand-name Zocor) is used in combination with Zetia and sold under the name Vytorin. Under the new Vytorin warning, the FDA recommends that 80 mg Vytorin not be prescribed for new patients and only be used in current patients who have used the medication successfully for at least 12 months with no sign of muscle injury. According to the FDA, use of the 80 mg dose of simvastatin can cause myopathy, a potentially serious muscle injury.
Up to seven percent of statin users experience muscle problems, and if a higher dose of Vytorin is prescribed, that statistic rises to more than 10 percent. Recent medical studies have shown that long-term use, and higher dosage use of Vytorin may result in statin Cardiomyopathy.
Cardiomyopathy is a serious weakening of the heart muscle, characterized by the heart' inability to pump blood and normally attributed to a reduced supply of oxygenated blood to the heart. It is a known adverse side effect of statin therapy and often goes unreported.
Researchers have recently found that statins, including Vytorin, activate atrogen-1, a gene signal in muscles. When this gene is activated, it drives the process of muscle destruction and degeneration, including the cardiac muscle in failing hearts.
Ironically, statins such as Vytorin that are prescribed to lower cholesterol and prevent heart problems may indeed be the cause of heart failure.
The goal of the ENHANCE study was to indicate that Vytorin was more effective than Zocor alone in preventing progression of atherosclerosis in the carotid (neck) artery. Instead, the study showed that, while both Vytorin and Zetia were found to have significantly reduced cholesterol in patients, neither drug provided any significant benefit versus the statin drug Zocor in slowing down clogging of the arteries.
The ENHANCE Study
Federal and state regulators asked why results of the ENHANCE trial, which ended in April of 2006, were not released to the public until January 14, 2008. Not only did Merck and Schering-Plough withhold the study results; according to the New York Times, the drug makers also tried to change the ENHANCE study's endpoint. The endpoint is the main medical result the study was meant to measure, and it is generally accepted among scientists that for a clinical trial to be valid, the endpoint must never change.
Vytorin Heart Problems
Vytorin Liver Damage and Heart Attack Risk
Anyone taking Vytorin who has had a cardiovascular event or clear evidence of clogged arteries may be at high risk. According to Allen Taylor, chief of cardiology at Walter Reed Army Medical Center in Washington, studies hint that Zetia (a component of Vytorin) might also "have some detrimental effect on the arteries".
Plaque buildup is a major risk factor for heart attacks and stroke. Vytorin or Zetia were prescribed to people with high cholesterol on the assumption that the drugs would reduce this risk.
The American Heart Association (AHA) says that the ENHANCE study looked at physical changes in artery walls, not at whether Vytorin did a better job of preventing heart attacks or deaths, and there won't be conclusive reports until a large study is completed in 2011. "I don't think there's significant information to direct change," says AHA president Daniel Jones. (The AHA received nearly $2 million in contributions from Vytorin maker Merck/Schering-Plough the previous year.)
Stroke warning signs from The American Stroke Association:
Another cause for concern is that Vytorin and other statins are known to increase levels of liver enzyme.
Vytorin, made by Merck and Schering-Plough, lowers low-density lipoprotein (LDL, or bad cholesterol). Statins, the largest family of cholesterol inhibitors and for the longest time the most potent, directly inhibit HMG-CoA reductase, the rate limiting enzyme of cholesterol synthesis. Inhibition can cause myopathy, a severe muscle wasting condition, and elevated liver enzymes.
Increased liver enzymes do not necessarily mean the liver is damaged. ( However, the statin drug Lipitor warns consumers on its package insert of "liver problems and adrenal insufficiency.") Increases in liver enzymes occur in up to 3.6 percent of people taking Vytorin. This increase appears to be more prevalent in patients who are taking higher doses.
Liver enzymes are usually measured to see if a person has liver damage. If your liver enzyme levels are high, your doctor may continue to test them on a more frequent basis. They do not measure how well the liver is working. An increase in liver enzymes can cause the following:
Several symptoms can occur in someone who develops liver problems while taking Vytorin. You should contact your healthcare provider if you have any of the following problems:
Vytorin lawsuits allege that Merck and Schering-Plough knew at the end of the ENHANCE trial that Vytorin was ineffective at reducing artery clogging plaque, heart attacks and strokes, but purposely kept that information from the public and the medical community. It may also have known about liver damage.
In August 2009 pharmaceutical manufacturers Merck and Schering-Plough (now merged into one company) agreed to settle a number of Vytorin and Zetia class action lawsuits, which claim the drugs are unsafe and ineffective, for $41.4 million. This settlement involves more than 140 claims pending in federal court in New Jersey filed by Vytorin and Zetia consumers and insurers. However, attorneys are still evaluating Vytorin claims and more Vytorin lawsuits are expected.
Vytorin Heart Attack and Liver Damage Legal HelpIf you or a loved one has suffered liver damage or a heart attack while taking Vytorin, please click the link below to send your complaint to a lawyer to evaluate your claim at no cost or obligation.
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My mother (69) has been diagnosed with small cell carcinoma of the liver (extremely rare). Prognosis 2-4 months to live. With chemo, maybe 4-8 months. Absolutely no history of cancer in family....ever
Had a kidney transplant lasting 12years never had a problem and my kidney stopped because of the drug
I took Vytorin for 6 months and went into renal failure 3 years ago, my kidneys are damaged and I need to start dialysis soon if I want to live. I have beeen hospitalized 5 times in 3 years with renal failure because of this drug.
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